Regional Patient Safety Associate - Pharmacovigilance F/M

Descripción del puesto:

Ipsen est un groupe biopharmaceutique mondial spécialisé dans le développement de médicaments innovants en oncologie, en neurosciences et dans les maladies rares. Notre objectif est d'améliorer la qualité de vie des patients. Ipsen bénéficie également d'une présence significative en Santé Familiale. Nous sommes engagés dans la recherche de solutions nouvelles à des maladies invalidantes ciblées et pour l'amélioration de la qualité de vie du patient. Chez Ipsen, nous avons une mission clair
**Summary / Purpose of the Mission** Join our team as a Pharmacovigilance Coordinator, where you will play a crucial role in overseeing and enhancing Pharmacovigilance (PV) activities across North and South America. You will ensure the robustness of the Ipsen PV System, working closely with Ipsen affiliates and commercial partners. Your efforts will support the GPS Regional Lead for the Americas, maintaining oversight and fostering strong interactions with local PV teams and stakeholders. Your mission is to deliver efficient, cost-effective, and compliant PV processes that meet global regulatory standards. **Main Responsibilities** 1. **Support GPS Regional Team**: Contribute to the strong oversight of all PV activities performed by Ipsen Affiliates and partners in the Americas. 2. **Maintain PV Systems**: Assist Ipsen Affiliate PV Offices in upholding their PV systems in line with global policies and regulations. 3. **Ensure Compliance**: Work with the GPS Regional Team to ensure affiliate and partner compliance with defined processes and contracts. 4. **Liaise with Commercial Partners**: Collaborate with local PV representatives and Marketing Authorization Holders (MAH) to ensure the performance and compliance of PV services. 5. **Review PV Documentation**: Support the GPS Regional Team in reviewing and approving PV documentation for Patient Data Collection Systems (PDCS) and Digital Media (DM) initiatives in the Americas. 6. **Develop Oversight Tools**: Build and maintain an oversight tool for the LATAM region, tracking activities, requirements, and partnership statuses. 7. **Support Global Initiatives**: Assist other team members with responsibilities in other regions and participate in transversal projects such as integrations and global initiatives. **Detailed Missions** - Participate in catch-up meetings with each Affiliate PV team in the Americas. - Draft meeting minutes and track pending actions. - Coordinate follow-up actions with stakeholders within the GPS organization and other global departments. - Prepare for catch-up meetings, including: - Drafting meeting minutes - Reviewing Affiliate PDCS Compliance / ATOLS - Reviewing Affiliate DM Compliance / Comando - Checking Affiliate Monthly Reports - Handle requests from GPS to Affiliates in the Americas for regional team oversight. - Assist in preparing slides for monthly affiliate meetings and GPS organization. - Implement relevant changes to global quality documents impacting affiliate processes. - Support affiliates with questions related to Ipsen requirements by coordinating responses with Subject Matter Experts. - Conduct quality checks of monthly reports from affiliates and partner PV teams to ensure data accuracy and completeness. - Escalate any identified issues to the GPS Regional Lead and Manager for the Americas. - Assist in the PV certification of PDCS and DM. - Participate in Affiliate PV Audit preparation and review audit responses with the GPS Regional Lead or Manager

Requerimientos del candidato/a:

Qualification Education / Certifications: * Fluent in written and spoken English * Have a basic knowledge of pharmaceutical industry and Good Pharmacovigilance Practices Languages: Technical competencies Key Technical Competencies Required * Ability to work in a matrix environment * Team player with good networking * Ability to prioritise own workload, work under pressure and achieve strict timeline targets * Good verbal and written communication skills